HypertensionNCT05966597
Written Behavioural Persuasion Technique Intervention for Hypertension Management
A study testing Written persuasive leaflet and Standard referral leaflet in people with Hypertension and Behavior and Behavior Mechanisms, run by Monash University Malaysia at 1 site in Malaysia.
Trial summary
This study aims to examine the feasibility and effectiveness of written behavioural persuasion techniques intervention to encourage treatment initiation and follow-up for hypertension management among the untreated hypertension population of the SEACO cohort. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hypertension, Behavior and Behavior Mechanisms
- What is being tested?
- Written persuasive leaflet and Standard referral leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 893 participants
- Where
- 1 siteMalaysia
- Study dates
- 14 Sep 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35 and above
- Systolic blood pressure equal to or more than 140 mmHg
- Diastolic blood pressure equal to or more than 90 mmHg
- reported not being diagnosed with hypertension OR not being treated for hypertension
Who cannot join
- Involve in other research projects
- decline to participate/reject
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
South East Asia Community Observatory, Monash University Malaysia
Segamat, Johor, 85000
About this study
Official title: Effectiveness of Written Behavioural Persuasion Technique Intervention for Hypertension Management Among The Untreated Hypertension Population of The Community Observatory in Segamat, Johor: a 2-arm Randomised Controlled Trial Within Cohort
This study aims to examine the feasibility and effectiveness of written behavioural persuasion techniques intervention to encourage treatment initiation and follow-up for hypertension management among the untreated hypertension population of the SEACO cohort.
Read the detailed description
Each household is given a unique identifier called house_id in the SEACO database. The randomisation will be computer-generated according to their house_id with a ratio of 1:1. During the house visit, participants' blood pressure will be taken three times, and the final reading will be the average of the second and third readings. Participants will be assessed based on the inclusion and exclusion criteria, i.e., age 35 years and above, blood pressure reading and reported not being diagnosed with or treated for hypertension. At the end of the house visit, all participants will receive a standard referral leaflet, and participants randomised to the intervention group will receive an additional written behavioural persuasion leaflet.
- Conditions
- Hypertension, Behavior and Behavior Mechanisms
- Being tested
- Written persuasive leaflet, Standard referral leaflet
- Medical subject headings
- Hypertension, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written persuasive leafletBehavioural
Additional written behavioural persuasive technique leaflet and a standard referral leaflet provided at the end of the home-based health screening.
Standard referral leafletBehavioural
Standard referral leaflet provided at the end of the home-based health screening.
| Study group | Role | What they receive |
|---|---|---|
| Written persuasive leaflet | Experimental | Participants will receive a written persuasive leaflet in addition to the standard referral leaflet. Receives: Behavioral: Written persuasive leaflet; Behavioral: Standard referral leaflet |
| Standard referral leaflet | Sham comparator | Participants will receive a standard referral leaflet. Receives: Behavioral: Standard referral leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who see a doctor because of high blood pressure
The number of participants who see a doctor because of high blood pressure
Measured: Follow-up after 4-6 weeks receiving the leaflet
Participants' intention to go see the doctor about their blood pressure (6-point Likert scale)
6-point Likert scale (strongly agree, moderately agree, somewhat agree, somewhat disagree, moderately disagree, strongly disagree) to measure participants' intention to go see the doctor about their blood pressure - "I intend to go to the doctor about my blood pressure", "I plan to go to the doctor about my blood pressure", "I want to go to the doctor about my blood pressure")
Measured: Follow-up after 4-6 weeks receiving the leaflet
Participants' awareness of receiving the written communication during the health visit and their perceptions of the leaflets (6-point Likert scale)
6-point Likert scale (strongly agree, moderately agree, somewhat agree, somewhat disagree, moderately disagree, strongly disagree) to measure participants' awareness of receiving the leaflets during the health visit and their perceptions of the leaflets' content, usefulness, impact on seeking medical attention, and aesthetic appeal - "The leaflets contain useful information", "The leaflet was helpful. It made it easier for me to see a doctor and manage my blood pressure/ It would make it easier for me to see a doctor and manage my blood pressure", "The leaflet was persuasive. It made me want to see a doctor for my blood pressure", "I like the colour and design of the leaflet".
Measured: Follow-up after 4-6 weeks receiving the leaflet
12-item Health Literacy score
12-item Health Literacy is a validated, self-reported instrument used to measure health literacy (HL). The index value for HL is obtained where 0 represents the lowest HL and 50 the highest HL
Measured: Follow-up after 4-6 weeks receiving the leaflet
Secondary outcomes (2)
Time taken for clinic visit (week)
Time taken (week) for participants to go see a doctor because of high blood pressure after receiving the leaflet
Measured: Follow-up after 4-6 weeks receiving the leaflet
Blood pressure status during clinic visit
Participants' self-reported blood pressure status during the visit to the clinic/doctor (low, normal, high)
Measured: Follow-up after 4-6 weeks receiving the leaflet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start14 Sep 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Principal investigator, Tin Tin Su, Monash University Malaysia
- Investigators
- Tin Tin Su, Principal investigator, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966597
- Sponsor's protocol ID
- MUHREC38735
- Status last verified
- May 2025
- First submitted
- 20 Jul 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available. The MUHREC requirement to comply with the term "Retention and storage of data - The Chief Investigator is responsible for the storage and retention of the original data pertaining to the project for a minimum period of five years".
Publications
Duong TV, Aringazina A, Kayupova G, Nurjanah, Pham TV, Pham KM, Truong TQ, Nguyen KT, Oo WM, Su TT, Majid HA, Sorensen K, Lin IF, Chang Y, Yang SH, Chang PWS. Development and Validation of a New Short-Form Health Literacy Instrument (HLS-SF12) for the General Public in Six Asian Countries. Health Lit Res Pract. 2019 Apr 10;3(2):e91-e102. doi: 10.3928/24748307-20190225-01. eCollection 2019 Apr.
PubMed 31294310
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Written Behavioural Persuasion Technique Intervention for Hypertension Management Among The Untreated Hypertension Population of The Community Observatory in Segamat, Johor: a 2-arm Randomised Controlled Trial Within Cohort
- ClinicalTrials.gov ID
- NCT05966597
- Acronym / sponsor ID
- MUHREC38735
- Conditions
- Hypertension, Behavior and Behavior Mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the feasibility and effectiveness of written behavioural persuasion techniques intervention to encourage treatment initiation and follow-up for hypertension management among the untreated hypertension population of the SEACO cohort.
Detailed description
Each household is given a unique identifier called house_id in the SEACO database. The randomisation will be computer-generated according to their house_id with a ratio of 1:1. During the house visit, participants' blood pressure will be taken three times, and the final reading will be the average of the second and third readings. Participants will be assessed based on the inclusion and exclusion criteria, i.e., age 35 years and above, blood pressure reading and reported not being diagnosed with or treated for hypertension. At the end of the house visit, all participants will receive a standard referral leaflet, and participants randomised to the intervention group will receive an additional written behavioural persuasion leaflet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written persuasive leaflet | Experimental | Behavioral: Written persuasive leaflet, Behavioral: Standard referral leafletParticipants will receive a written persuasive leaflet in addition to the standard referral leaflet. |
| Standard referral leaflet | Sham comparator | Behavioral: Standard referral leafletParticipants will receive a standard referral leaflet. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 35 and above
- Systolic blood pressure equal to or more than 140 mmHg
- Diastolic blood pressure equal to or more than 90 mmHg
- reported not being diagnosed with hypertension OR not being treated for hypertension
Key exclusion criteria (2 listed)
- Involve in other research projects
- decline to participate/reject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written persuasive leafletAdditional written behavioural persuasive technique leaflet and a standard referral leaflet provided at the end of the home-based health screening. | Behavioural | Written persuasive leaflet |
| Standard referral leafletStandard referral leaflet provided at the end of the home-based health screening. | Behavioural | Standard referral leaflet, Written persuasive leaflet |
Primary outcome
Number of participants who see a doctor because of high blood pressure
Time frame: Follow-up after 4-6 weeks receiving the leaflet
The number of participants who see a doctor because of high blood pressure
Participants' intention to go see the doctor about their blood pressure (6-point Likert scale)
Time frame: Follow-up after 4-6 weeks receiving the leaflet
6-point Likert scale (strongly agree, moderately agree, somewhat agree, somewhat disagree, moderately disagree, strongly disagree) to measure participants' intention to go see the doctor about their blood pressure - "I intend to go to the doctor about my blood pressure", "I plan to go to the doctor about my blood pressure", "I want to go to the doctor about my blood pressure")
Participants' awareness of receiving the written communication during the health visit and their perceptions of the leaflets (6-point Likert scale)
Time frame: Follow-up after 4-6 weeks receiving the leaflet
6-point Likert scale (strongly agree, moderately agree, somewhat agree, somewhat disagree, moderately disagree, strongly disagree) to measure participants' awareness of receiving the leaflets during the health visit and their perceptions of the leaflets' content, usefulness, impact on seeking medical attention, and aesthetic appeal - "The leaflets contain useful information", "The leaflet was helpful. It made it easier for me to see a doctor and manage my blood pressure/ It would make it easier for me to see a doctor and manage my blood pressure", "The leaflet was persuasive. It made me want to see a doctor for my blood pressure", "I like the colour and design of the leaflet".
12-item Health Literacy score
Time frame: Follow-up after 4-6 weeks receiving the leaflet
12-item Health Literacy is a validated, self-reported instrument used to measure health literacy (HL). The index value for HL is obtained where 0 represents the lowest HL and 50 the highest HL
2 secondary outcomes
Time taken for clinic visit (week)
Time frame: Follow-up after 4-6 weeks receiving the leaflet
Blood pressure status during clinic visit
Time frame: Follow-up after 4-6 weeks receiving the leaflet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 31294310Duong TV, Aringazina A, Kayupova G, Nurjanah, Pham TV, Pham KM, Truong TQ, Nguyen KT, Oo WM, Su TT, Majid HA, Sorensen K, Lin IF, Chang Y, Yang SH, Chang PWS. Development and Validation of a New Short-Form Health Literacy Instrument (HLS-SF12) for the General Public in Six Asian Countries. Health Lit Res Pract. 2019 Apr 10;3(2):e91-e102. doi: 10.3928/24748307-20190225-01. eCollection 2019 Apr.
- Individual participant dataSharing planned: No. There is no plan to make IPD available. The MUHREC requirement to comply with the term "Retention and storage of data - The Chief Investigator is responsible for the storage and retention of the original data pertaining to the project for a minimum period of five years".
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tin Tin Su principal investigator
Monash University Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written persuasive leaflet and Standard referral leaflet in people with Hypertension and Behavior and Behavior Mechanisms, run by Monash University Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who see a doctor because of high blood pressure (time frame: Follow-up after 4-6 weeks receiving the leaflet). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.